J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Shots:

  • J&J and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development
  • Janssen will commit ~$604M while BARDA will commit ~$454M to support the ongoing P-lll ENSEMBLE study assessing Janssen’s JNJ-78436735 as a single-dose in ~60,000 patients globally
  • J&J affirmed its commitment to develop and test its vaccine candidate in accordance with high ethical standards and sound scientific principles, as outlined in a pledge made by 9 vaccine manufacturers in early 2020

Click here­ to­ read full press release/ article | Ref: PR Newswire | Image: Courier Journal

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GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Shots:

  • GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response
  • The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults (60-80yrs.) with different dosages of antigen & adjuvant. The interim data 1mos. post-immunization elicited a robust humoral and cellular immunity while the vaccine includes AS01 adjuvant system to boost the immune response
  • GSK3888550A was tested with 3 different doses vs PBO in 502 healthy non-pregnant women over monthly visits (day 8, 31 & 91 post immunization). The study results demonstrated that vaccine rapidly boost pre-existing immunity at all dose levels & @day8 it showed a 4-fold increase in RSV-A and RSV-B neutralizing Abs titers. P-III studies of both the vaccines are expected to initiate in the coming months

Click here ­to­ read full press release/ article | Ref: GSK | Image: Reuters

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BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots:

  • The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process to facilitate the final MAA
  • BNT162b2 vaccinated participants showed a favorable breadth of epitopes recognized in T-cell responses specific to SARS-CoV-2 spike antigen & BNT162b2 demonstrated concurrent induction of high magnitude CD4+ & CD8+ T cell responses which are TH-1 dominant against RBD and remainder of full spike glycoprotein
  • BNT162b2 vaccine candidate (BioNTech’s proprietary mRNA technology and supported by Pfizer) encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S). It is currently being evaluated in an ongoing P-III study with ~37,000 participants enrolled and 28,000 having received their second vaccination at >120 clinical sites worldwide including the US, Brazil, South Africa, and Argentina

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: King’s College London

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Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots:

  • The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2
  • The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 – 85yrs. started in the US and is expected to include ~120 sites globally 
  • Assuming clinical success, companies expect to seek regulatory approval as early as Oct’2020. Following the approval, the companies currently aim to supply globally up to 100M doses by the end of 2020 and ~1.3B doses by the end of 2021. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus-neutralizing Abs and has received the US BT designation

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: StraitTimes

Related News: Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19